Effectiveness of a Treatment With the Robot - Assisted Gait Training System Walkbot in Patients With Cerebral Palsy

Universidad de Murcia

Status: Completed

Conditions: Cerebral Palsy

Treatments: Other: Physical Therapy; Device: Assisted gait training with Walkbot System

Study type: Interventional

Funder types: Other

Identifiers

NCT04329793

2365/2019

Details and patient eligibility

About

The improvement of walking capacity is a key objective of the rehabilitation of children with PC. There are different approaches from physiotherapy to address this need, including walking on the ground and on treadmill with partial weight support. Currently, there are robotic technologies adapted to the functional rehabilitation of patients. Assisted gait training with robotic devices such as the Walkbot allows a longer duration of training, at more variable speeds, and with a constant gait pattern adapted to the patient. This training, based on the intensity and repetition of the movement, has beneficial effects on the recovery and improvement of the patient's postural and locomotor functions.

There are some studies that evaluate walking interventions on treadmill with partial weight support, on the ground and in assisted walking robot in patients with PC.

Currently, there are no studies conducted that report the effectiveness of interventions performed with robotic walking training device Walkbot K on PC. However, studies in adults with Walkbot S, affected with neurological injury, have reported good results.

Assisted gait training with robotic devices such as the Walkbot, based on the intensity and repetition of the movement, has beneficial effects on the recovery and improvement of the patient's postural and locomotor functions. However, due to the little evidence that exists, it is necessary to know the effectiveness of the Walkbot assisted walking robot in these patients by means of a clinical trial that allows to firmly establish the scope of its benefits.

Enrollment: 23 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Cerebral palsy diagnosis (diplegia or tetraplegia)
• Ability to communicate even if not verbal (yes/not; gestures; pictograms; sounds)
• Levels II, III and IV in GMFCS
• Unsupported seating capacity
• Go on standing with or without help
• Not receiving therapy with a walking robot and not having received it in at least one year

Exclusion criteria

• Serious psychiatric problems
• Serious heart problems
• Active tumors
• Severe joint degenerative problems
• Degenerative diseases of the nervous system
• Mitochondrial diseases
• Recent surgeries
• Unbound fractures
• Severe osteoporosis
• Uncontrolled seizures
• Open wounds in the lower half of the body
• Extreme fear of being placed in robotic devices
• Anthropomorphic measures are below the minimum required to use the device

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Intervention arm

Experimental group

Description:

Assisted gait training with Walkbot System and their usual Physical Therapy.

Treatment:

Other: Physical Therapy

Device: Assisted gait training with Walkbot System

Control arm

Active Comparator group

Description:

Their usual Physical Therapy.

Treatment:

Other: Physical Therapy